1. Field of the Invention
The present invention relates in general to iontophoretic delivery devices used to deliver ionic medicaments through the skin or other tissues, and more particularly, to crushable hydration assemblies for hydrating a bioelectrode element of an iontophoretic delivery device.
2. Background Art
lontophoretic delivery devices have been known in the art for several years. Furthermore, iontophoretic delivery devices having hydration assemblies for hydrating bioelectrodes are likewise well known and are the subject of many U.S. Patents including: PCT Application No. WO/93/24177; PCT Application No. WO/92/07619; U.S. Pat. No. 5,730,716; and U.S. Pat. No. 5,645,527.
PCT Application No. WO/93/24177 discloses an iontophoretic delivery device which includes drug and electrolyte matrix pads that are initially unfilled, in a non-hydrated state. A sealed liquid-containing capsule or pouch is provided in each electrode assembly. Water or other liquid is released from the pouch by pulling a tab attached to a portion of the pouch which is capable of being torn or ripped in order to hydrate the drug and electrolyte reservoirs. The ""177 application further discloses a device which includes liquid storage pouches which move through a compression zone when removing the device from an outer package. The compression forces a puncturing device to break into the pouches and in turn, releases the associated liquid.
PCT Application No. WO/92/07619 discloses an iontophoretic drug delivery electrode and method of hydrating the same. In particular, the device includes drug and electrolyte matrix pads which are initially in a non-hydrated state. Liquid can be contained in breakable capsules within a pouch. The capsules are broken by directly squeezing or flexing the pouches. The ""619 application further discloses an iontophoretic drug delivery device wherein fluid is released from a pouch using piercing pins.
U.S. Pat. No. 5,730,716 discloses an iontophoretic delivery device which includes a xe2x80x9cpouchxe2x80x9d like hydration assembly that, upon displacement of a pull tab, unfolds, thereby releasing medicament and/or an electrolyte solution therefrom.
U.S. Pat. No. 5,645,527 discloses a hydration assembly for hydrating a bioelectrode, wherein the hydration assembly can be activated by a user through application of force to a pocket in a side of a sealed-liquid storage component to cause the pocket to become inverted and substantially align with an opposing pocket in the other side such that the sealed liquid-storage compartment unseals at a predetermined release location.
The present invention is directed to a hydratable bioelectrode for use in an iontophoretic delivery device comprising: (a) a hydrating component, wherein the hydrating component includes: (1) a cradle having a chamber capable of retaining one or more fluid containing ampules and (2) at least one displaceable flange associated with the cradle which is capable of breakably engaging one or more fluid containing ampules retained within the chamber upon application of an applied force; and (b) a bioelectrode component associated with the hydrating component.
In a preferred embodiment of the invention, the at least one displaceable flange comprises a pair of substantially parallel inwardly depressable flanges.
Preferably the cradle further comprises one or more ampule engaging tabs positioned on an inner surface of the same.
In another preferred embodiment of the invention, the hydratable bioelectrode further comprises means for substantially precluding ampule breakage from contacting the bioelectrode component. In this embodiment the ampule breakage contacting preclusion means may include a mesh, scrim, or screen guard positioned between the hydrating component and the bioelectrode component.
In yet another preferred embodiment of the present invention, the bioelectrode component is slidably, snapidly, hingedly, adhesively, or otherwise fixiated mounted to a chassis member of an iontophoretic delivery device. The present invention is also directed to an iontophoretic delivery device, comprising: (a) a cradle having a chamber containing one or more fluid containing ampules; (b) ampule breaking means associated with the cradle for rapidly breaking the one or more fluid containing ampules; and (c) a bioelectrode component associated with the hydrating component.
The present invention is further directed to a process for hydrating a hydratable bioelectrode, comprising the steps of: (a) providing a hydrating component including a cradle having a chamber filled with one or more fluid containing ampules and at least one displaceable flange associated with the cradle; (b) providing a bioelectrode component; (c) displacing the at least one displaceable flange with an applied force; (d) breaking the one or more fluid containing ampules with the displaced flange; and (e) releasing the fluid from the one or more ampules onto the bioelectrode component.
Preferably the step of displacing the at least one displaceable flange with an applied force includes the step of inwardly depressing the same.